Mastering ISO 15378: A Step-by-Step Guide to Implementation and Certification
Course Overview This comprehensive course is designed to provide participants with a thorough understanding of the ISO 15378 standard and its implementation in the primary packaging materials for medicinal products. Participants will gain hands-on experience with the tools and techniques necessary for a successful implementation and certification process.
Course Objectives - Understand the requirements of the ISO 15378 standard
- Implement a quality management system (QMS) that meets the standard's requirements
- Develop a plan for certification and maintenance of the QMS
- Conduct internal audits and management review
- Improve the overall quality and safety of primary packaging materials for medicinal products
Course Outline Module 1: Introduction to ISO 15378
- Overview of the ISO 15378 standard
- History and development of the standard
- Key concepts and terminology
- Benefits of implementing the standard
Module 2: Quality Management System (QMS) Requirements
- Quality policy and objectives
- Quality manual and procedures
- Organization and management structure
- Responsibilities and authorities
Module 3: Design and Development
- Design and development process
- Design and development planning
- Design and development inputs
- Design and development outputs
- Design and development review
- Design and development validation
Module 4: Production and Service Provision
- Production planning and control
- Service provision planning and control
- Release of products and services
- Control of nonconforming products and services
Module 5: Measurement, Analysis, and Improvement
- Measurement and monitoring
- Analysis and evaluation
- Improvement and corrective action
- Preventive action
Module 6: Internal Audits and Management Review
- Internal audit process
- Internal audit planning and preparation
- Internal audit execution and reporting
- Management review process
- Management review inputs and outputs
Module 7: Certification and Maintenance
- Certification process
- Certification body selection
- Certification audit preparation
- Certification audit execution and reporting
- Maintenance of certification
Module 8: Implementation and Transition
- Implementation planning and preparation
- Implementation execution and monitoring
- Transition planning and preparation
- Transition execution and monitoring
Course Features - Interactive and engaging: The course includes interactive lessons, quizzes, and games to keep participants engaged and motivated.
- Comprehensive and personalized: The course covers all aspects of the ISO 15378 standard and provides personalized feedback and guidance.
- Up-to-date and practical: The course is updated regularly to reflect the latest developments and best practices in the field.
- Real-world applications: The course includes real-world examples and case studies to illustrate the application of the standard.
- High-quality content: The course is developed by experts in the field and includes high-quality content and resources.
- Expert instructors: The course is taught by experienced instructors who are experts in the field.
- Certification: Participants receive a certificate upon completion of the course, issued by The Art of Service.
- Flexible learning: The course is available online and can be completed at the participant's own pace.
- User-friendly: The course is designed to be user-friendly and easy to navigate.
- Mobile-accessible: The course is accessible on mobile devices, allowing participants to learn on-the-go.
- Community-driven: The course includes a community forum where participants can connect with each other and ask questions.
- Actionable insights: The course provides actionable insights and practical advice that participants can apply in their own organizations.
- Hands-on projects: The course includes hands-on projects and activities that allow participants to apply their knowledge and skills.
- Bite-sized lessons: The course is divided into bite-sized lessons that can be completed in a short amount of time.
- Lifetime access: Participants have lifetime access to the course materials and resources.
- Gamification: The course includes gamification elements, such as badges and points, to make learning fun and engaging.
- Progress tracking: The course includes a progress tracking system that allows participants to track their progress and stay motivated.
Certificate Upon completion of the course, participants will receive a certificate issued by The Art of Service. The certificate is recognized internationally and demonstrates the participant's knowledge and skills in implementing and maintaining a quality management system that meets the requirements of the ISO 15378 standard.,
- Understand the requirements of the ISO 15378 standard
- Implement a quality management system (QMS) that meets the standard's requirements
- Develop a plan for certification and maintenance of the QMS
- Conduct internal audits and management review
- Improve the overall quality and safety of primary packaging materials for medicinal products
Course Outline Module 1: Introduction to ISO 15378
- Overview of the ISO 15378 standard
- History and development of the standard
- Key concepts and terminology
- Benefits of implementing the standard
Module 2: Quality Management System (QMS) Requirements
- Quality policy and objectives
- Quality manual and procedures
- Organization and management structure
- Responsibilities and authorities
Module 3: Design and Development
- Design and development process
- Design and development planning
- Design and development inputs
- Design and development outputs
- Design and development review
- Design and development validation
Module 4: Production and Service Provision
- Production planning and control
- Service provision planning and control
- Release of products and services
- Control of nonconforming products and services
Module 5: Measurement, Analysis, and Improvement
- Measurement and monitoring
- Analysis and evaluation
- Improvement and corrective action
- Preventive action
Module 6: Internal Audits and Management Review
- Internal audit process
- Internal audit planning and preparation
- Internal audit execution and reporting
- Management review process
- Management review inputs and outputs
Module 7: Certification and Maintenance
- Certification process
- Certification body selection
- Certification audit preparation
- Certification audit execution and reporting
- Maintenance of certification
Module 8: Implementation and Transition
- Implementation planning and preparation
- Implementation execution and monitoring
- Transition planning and preparation
- Transition execution and monitoring
Course Features - Interactive and engaging: The course includes interactive lessons, quizzes, and games to keep participants engaged and motivated.
- Comprehensive and personalized: The course covers all aspects of the ISO 15378 standard and provides personalized feedback and guidance.
- Up-to-date and practical: The course is updated regularly to reflect the latest developments and best practices in the field.
- Real-world applications: The course includes real-world examples and case studies to illustrate the application of the standard.
- High-quality content: The course is developed by experts in the field and includes high-quality content and resources.
- Expert instructors: The course is taught by experienced instructors who are experts in the field.
- Certification: Participants receive a certificate upon completion of the course, issued by The Art of Service.
- Flexible learning: The course is available online and can be completed at the participant's own pace.
- User-friendly: The course is designed to be user-friendly and easy to navigate.
- Mobile-accessible: The course is accessible on mobile devices, allowing participants to learn on-the-go.
- Community-driven: The course includes a community forum where participants can connect with each other and ask questions.
- Actionable insights: The course provides actionable insights and practical advice that participants can apply in their own organizations.
- Hands-on projects: The course includes hands-on projects and activities that allow participants to apply their knowledge and skills.
- Bite-sized lessons: The course is divided into bite-sized lessons that can be completed in a short amount of time.
- Lifetime access: Participants have lifetime access to the course materials and resources.
- Gamification: The course includes gamification elements, such as badges and points, to make learning fun and engaging.
- Progress tracking: The course includes a progress tracking system that allows participants to track their progress and stay motivated.
Certificate Upon completion of the course, participants will receive a certificate issued by The Art of Service. The certificate is recognized internationally and demonstrates the participant's knowledge and skills in implementing and maintaining a quality management system that meets the requirements of the ISO 15378 standard.,
- Interactive and engaging: The course includes interactive lessons, quizzes, and games to keep participants engaged and motivated.
- Comprehensive and personalized: The course covers all aspects of the ISO 15378 standard and provides personalized feedback and guidance.
- Up-to-date and practical: The course is updated regularly to reflect the latest developments and best practices in the field.
- Real-world applications: The course includes real-world examples and case studies to illustrate the application of the standard.
- High-quality content: The course is developed by experts in the field and includes high-quality content and resources.
- Expert instructors: The course is taught by experienced instructors who are experts in the field.
- Certification: Participants receive a certificate upon completion of the course, issued by The Art of Service.
- Flexible learning: The course is available online and can be completed at the participant's own pace.
- User-friendly: The course is designed to be user-friendly and easy to navigate.
- Mobile-accessible: The course is accessible on mobile devices, allowing participants to learn on-the-go.
- Community-driven: The course includes a community forum where participants can connect with each other and ask questions.
- Actionable insights: The course provides actionable insights and practical advice that participants can apply in their own organizations.
- Hands-on projects: The course includes hands-on projects and activities that allow participants to apply their knowledge and skills.
- Bite-sized lessons: The course is divided into bite-sized lessons that can be completed in a short amount of time.
- Lifetime access: Participants have lifetime access to the course materials and resources.
- Gamification: The course includes gamification elements, such as badges and points, to make learning fun and engaging.
- Progress tracking: The course includes a progress tracking system that allows participants to track their progress and stay motivated.